final program.qxd - Parallels Plesk Panel

PP 1.17
In the Footsteps of the WHO - Rapid HIV Testing in America
Eugene Martin, Ph.D. 1 , Gratian Salaru, M.D. 1 , Sindy M. Paul, M.D., M.P.H. 2 ,
Evan Cadoff, M.D. 1
1
UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA
2
New Jersey Department of Health and Senior Services, Trenton, New Jersey
Background: In the United States, only 4 rapid HIV tests have received FDA approval. In
excess of 60 rapid HIV tests are in use worldwide. In some resource-poor countries,
confirmatory testing by alternative rapid assays is also in widespread use. In the United
States, rapid HIV testing allows preliminary positive results to be recognized in minutes,
but still requires traditional confirmation by complex, time-consuming methodologies. In
some cases, the reported sensitivity and specificity of rapid tests equals or exceeds that
of conventional enzyme immunoassays (EIA) as well as the confirmatory Western blot
and/or IFA tests they were intended to confirm. This results in large numbers of negative
or indeterminate confirmatory tests that require significant efforts to clarify.
In densely populated states such as New Jersey, efforts to control the spread of HIV relies
upon rapid HIV testing in a multitude of venues including outreach centers, satellite
facilities, hospital ERs, methadone clinics, perinatal clinics, and increasingly, mobile units.
Unfortunately, as many as 30% of preliminary positive HIV clients fail to receive final
results because of their unwillingness to return for a second visit and the goal of HIV
awareness remains hostage to an aging confirmatory methodology.
Objectives:To provide an update of rapid HIV testing in the United States, particularly in
New Jersey with an emphasis on the consequences of Western blot confirmation. An
alternative method of confirming a rapid HIV test with a second, alternate rapid HIV test
has been utilized retrospectively to assess the feasibility of confirming a rapid HIV result
with a secondary rapid HIV test.
Methods: Between July 1, 2004 and Feb 28, 2005 13,500 rapid HIV tests were
performed in New Jersey CTS locations identifying a total of 250 preliminary positive
individuals. Traditional confirmatory testing by Western Blot identified 9 cases as
discordant (.067%) i.e. a preliminary positive rapid test and a negative Western Blot.
Utilizing residual serum samples available in the public health laboratory repository,
alternative rapid HIV tests were performed using 3 other tests approved for use in the
United States including: Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad Laboratories,
Redmond, WA 98052), MedMira Reveal Rapid HIV-1 Antibody Test (MedMira
Laboratories, Inc, Halifax, Nova Scotia, Canada B3S 1B3), Uni-Gold (Trinity Biotech plc,
Wicklow, Ireland).
POSTERS
Results: Two of three alternative rapid tests (Trinity Uni-Gold (CLIA-waived) and MedMira
Reveal (moderate-complexity, non-CLIA-Waived) successfully identified all nine
discordant specimens as non-reactive. Of 355 Western blot confirmed rapid HIV
specimens collected between July 1, 2004 and April 19, 2005, 100% concordance was
obtained using all three available alternative rapid assays.
Conclusions: Rapid HIV testing has become a major means of increasing awareness of
HIV serostatus in the United States. Annually, use of a confirming rapid test algorithm in
New Jersey would allow an additional 91 HIV positive individuals to learn their definitive
status and would assure a better linkage to health care for affected individuals.
“ Focusing FIRST on PEOPLE “ 101 w w w . i s h e i d . c o m